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510(k) Data Aggregation

    K Number
    K220624
    Device Name
    AI4CMR v1.0
    Manufacturer
    AI4MedImaging Medical Solutions S.A.
    Date Cleared
    2022-07-22

    (141 days)

    Product Code
    LLZ, QIH
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    AI4MedImaging Medical Solutions S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AI4CMR software is designed to report cardiac function measurements (ventricle volumes, ejection fraction, indices etc.) from 1.5T and 3T magnetic resonance (MR) scanners. AI4CMR uses artificial intelligence to automatically segment and quantify the different cardiac measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making. The user incorporating AI4CMR into their DICOM application of choice is responsible for implementing a user interface.
    Device Description
    AI4CMR v1.0 is a cloud-hosted service used with any third-party DICOM viewer application where the DICOM viewer serves as the user interface and the interface to a PACS or scanner for AI4CMR. AI4CMR is implemented as a plug-in to the DICOM viewer by the user and automatically processes and analyses cardiac MR images received by the DICOM viewer to quantify relevant cardiac function metrics and makes the information available to the user at the user's discretion.
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